Minneapolis, MN Posted: 4/9/2019
Quality Technician/Direct Hire/$18-$25
Primary duties of this position will be to work from engineering drawings, work instructions and other established specifications to determine acceptance, rejection or rework requirements of product within company directives and operating procedures consistent with FDA, GMP, ISO 9001:2008 and ISO 13485:2003 guidelines. The Quality Technician III will have extensive experience in the setup, adjustment, alignment as well as a demonstrated ability to safely run complex inspection equipment. The Technician will perform visual and dimensional inspections using visual standards and inspection tools including programmable Coordinate Measuring Machines (CMM). They will create and run measuring programs using CMM software. They will use procedures including sampling plans to conduct component and assembly inspections. The Quality Technician II will also collect and analyze data using spreadsheet software programs.
5am to 530pm (12 hours, 36 week)
12% shift differential that gets them to 40 hours paid
- Performs tooling inspections.
- Performs first piece and product inspections as necessary for all Value Streams.
- Provides traceable verification by completing inspection documentation or other documents for all components, assemblies, and/or product lots inspected, as required by inspection documentation.
- Performs evaluation of returned goods to verify assembly integrity as requested by the Material Review Board (MRB).
- Maintains control of documentation, tools and product within the inspection work space.
- Provides training and feedback to associates in quality practices, acceptance criteria and measurement technique.
- Identifies processdiscrepancies and communicates them to appropriate advisors.
- Prepares necessary reports including documenting test results and statistics.
- Assists in the development of training for visual inspection.
- Maintains electronic inspection data using established procedures and file naming conventions.
- Retains records according to company policy and samples from inspections.
- Places equipment or product on hold when inspection records indicate product or equipment operation is found to be not capable of producing acceptable output.
- Trains others as needed in GD&T and quality practices.
- Participates in team meetings as required.
- Wears personal protective equipment as required.
- Maintains a clean work area and utilizes safe working practices.
- Performs all activities in compliance with Quality System requirements.
- Acts as a resource to Estimating/Planning and Engineering for the development of tooling as necessary.
- Acts as a resource for quality practices for all Value Streams.
- Creates complex programs as needed for the Coordinate Measuring Machines.
- High School diploma minimum.
- Post secondary education in a technical program preferred.
- 5-7 years of related experience in a manufacturing environment; medical device industry experience a plus.
- Formal training or experience with Lean manufacturing principles.
- Proficient using Microsoft office.
- Minitab experience required.
- Trained in FDA GMP and/or ISO 9001 and ISO 13485 guidelines.
- ASQ Certified Quality Technician or Certified Quality Technician certification a plus.
- Excellent communication and writing skills.
- Exhibits a professional demeanor at all times.
- Ability to read and understand verbal and written instructions.
- Ability to read and interpret complex engineering drawings and specifications.
- Advanced understanding of geometric dimensioning and tolerances.
- Identify process/product non-conformances or borderline quality conditions that may require corrective action.
- Working knowledge of inspection sampling plans (i.e., ANSI C=0).
- Excellent hand/eye coordination, manual dexterity, and vision.
- Detail oriented.
- Advanced working knowledge of quality control dimensional inspection tools such as Calipers, Micrometers and the programming and operation of Coordinate Measuring Machines.
- Can speak, understand and write English.
Konik PrimeStaff is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.
Konik PrimeStaff has been a leader in the technical staffing industry for more than 45 years, providing the fastest and easiest link between employees and employers. Konik PrimeStaff has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception and maintains a strong commitment to customer service.
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